On January 2022 the FDA assigned breakthrough therapy designation to telisotuzumab vedotin for advanced, previously treated, EGFR-wild-type, nonsquamous NSCLC with MET overexpression, based on the preliminary results of an ongoing phase 2 study evaluating this agent in previously treated patients with MET overexpressing NSCLC (NCT03539536) [98]. The gene discussed is MET; the disease is non-small cell lung carcinoma.